BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2931645 · Received January 24, 2013

    Report

    Report Number
    1644408-2013-00044
    Event Type
    Other
    Date Received
    January 24, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K041066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THE REVISION SURGERY ON (B)(6) 2013 WAS DUE TO AN INFECTION. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2012. THERE WAS NO INFORMATION SUBMITTED WITH THIS COMPLAINT ABOUT ANY PATIENT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO AN INFECTION. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. THE DEVICE HISTORY RECORDS FOR THE REPORTED COMPONENTS WERE EXAMINED. A REVIEW OF THE STERILIZATION RECORDS SHOW THE DEVICES ALL RECEIVED AN ADEQUATE 25-40 KGY GAMMA RADIATION STERILIZATION DOSE AND WERE WITHIN THEIR RESPECTIVE EXPIRATION DATES AT THE TIME OF THE ORIGINAL SURGERY. A REVIEW OF THE IMPLANT DEVICE HISTORY RECORDS, PRODUCT COMPLAINT REPORT DATABASE, AND STERILIZATION RECORDS SHOW THE REPORTED COMPONENTS USED IN THE ORIGINAL SURGERY MET STERILIZATION, DESIGN, AND MANUFACTURING REQUIREMENTS. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THE PATIENT WAS INVOLVED IN THAT MAY HAVE CONTRIBUTED TO THE INFECTION OR INHIBITED THE PATIENT'S IMMUNE SYSTEM. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE OF THE CONTROL OF DJO SURGICAL. THE DATA REVIEWED IN THIS REPORT SUPPORTS THAT THE INFECTION THE PATIENT WAS SUFFERING FROM WAS NOT THE RESULT OF A PRODUCT OR MANUFACTURING PROCESS DEFECT.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT HAD AN INFECTION IN THE SHOULDER. THE SURGEON DECIDED TO REMOVE ALL THE IMPLANTS FROM THE ORIGINAL SURGERY AND REPLACED THEM WITH A CEMENT SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33764 RSP SHOULDER STANDARD HUMERAL SOCKET INSERT KWS ENCORE MEDICAL, L.P. 855C1149

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 510-00-010, LOT 980F1035| 506-03-122, LOT 833C1067| 506-03-118 (X2), LOT 832C1065/1063| 508-00-031, LOT 855C1149| 508-32-101, LOT 862C1175| 508-32-104, LOT 866C1359